Surgical articles and methods

ABSTRACT

Described are devices, implants, kits, and related methods for treating pelvic conditions such as urinary in incontinence, in a male or a female patient. The invention includes, in one embodiment, a multi-piece implant, including a tissue support piece, extension portion, and one or more self-fixating tips. The device may be employed through a medial incision in the pelvic region of the patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of, and claims priority to, U.S.patent application Ser. No. 15/200,236, filed on Jul. 1, 2016, entitled“SURGICAL ARTICLES AND METHODS”, which claims priority to U.S. patentapplication Ser. No. 13/579,811, filed on Aug. 17, 2012, entitled“SURGICAL ARTICLES AND METHODS”, now U.S. Pat. No. 9,381,076, whichclaims the benefit from International Patent Application No.PCT/US2011/025917, filed on Feb. 23, 2011, entitled “SURGICAL ARTICLESAND METHODS”, which claims priority under 35 USC § 119(e) from U.S.Provisional Patent Application No. 61/307,264, filed on Feb. 23, 2010,entitled “SINGLE INCISION SLING AND METHOD THEREFOR”, the disclosures ofwhich are incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

The invention relates to apparatus and methods for treating urinaryincontinence by use of an implant to support urethral tissue.

BACKGROUND

Men, women, and children of all ages can suffer from urinaryincontinence or involuntary loss of urinary control. Their lives areperpetually interrupted by thoughts of ensuring that they have readyaccess to a restroom. Everyday activities such as attending a theater orsporting event can become unpleasant. Sufferers often begin to avoidsocial situations in an effort to reduce the stress associated withtheir condition.

A variety of treatment options are currently available. Some of theseinclude external devices, behavioral therapy (such as biofeedback,electrical stimulation, or Kegel exercises), prosthetic devices, andsurgery. Depending on the age, medical condition, and personalpreference of a patient, surgical procedures can be used to completelyrestore continence.

One type of surgical procedure found to be an especially successfultreatment option for incontinence in both men and women is a slingprocedure. Sling procedures typically entail surgically implanting abiocompatible implant or “sling” to support the bladder neck or urethra.Sling procedures are discussed in U.S. Pat. Nos. 5,112,344; 5,611,515;5,842,478; 5,860,425; 5,899,909; 6,039,686; 6,042,534; 6,110,101;6,478,727; 6,638,211; and PCT Publication Nos. WO 02/39890 and WO02/069781.

Some “pubomedial” sling procedures involve an abdominal incision andinstallation of a sling between the rectus fascia in the abdominalregion to a position below the urethra, and back again to the rectusfascia. A conventional procedure in females is to surgically place asling by entering the abdominal cavity through an incision in thepatient's pubovaginal region.

In males, one example of a conventional method involves surgicalplacement of a sling by entering the abdominal cavity through anabdominal incision. Unfortunately, to access the abdominal cavity asurgeon must incise the male patient's abdominal muscles. This procedureis more time consuming and uncomfortable for the male patient

Other methods for treating pelvic conditions involve installation of asling below the urethra through incisions made at the inner thigh (e.g.,in the perineal skin facing the obturator and in the groin), and using atissue path extending through the obturator. These procedures can bereferred to as “transobturator” methods. See, e.g., U.S. Pat. No.6,911,003 and Published U.S. Pat. Appl. No. 2003/0171644A1, theentireties of each being incorporated herein by reference.

While abdominal and transobturator methods of treating urinaryincontinence can be effective, safe, and long-lasting, there is ongoingeffort toward improving these methods.

SUMMARY

The invention relates to methods of treating pelvic conditions, e.g.,urinary incontinence, in males and females.

Certain embodiments of methods and implants involve placement of atissue support portion of an implant below a urethra, preferably withplacement of extension portions of the implant at tissue paths thatextend from a location to support the urethra in a direction toward anobturator foramen. A tissue path may extend toward and end at pelvicfascia without reaching or passing into or through the obturatorforamen. In other embodiments a tissue path may extend to the obturatorforamen. In still other embodiments the tissue path may extend throughan obturator foramen. The methods can involve two opposing tissue paths,as described, one on each of a left and a right side of the patient.

The implant may involve an adjustment feature that allows placement ofthe implant followed by or along with adjustment of the positioning orsize of the implant, such as one or more adjustable extension portion.The adjustment feature may be a one-way adjusting engagement, a two-wayadjusting engagement feature, a two-way adjusting feature thatadditionally includes a locking feature, etc. A method may involveadjusting the size of the implant by use of an adjusting feature oradjusting engagement between an extension portion and a support portion.The implant may be placed and optionally adjusted by use of a tool thatcan contact an implant to allow manipulation of the implant; optionallyat the same time the tool may allow for or may be used to providemovement or approximation of tissue to be supported by the implant(e.g., tissue of a urethra).

In one aspect, the invention relates to a system for treating urinaryincontinence, the system including a multi-piece implant comprising asupport portion piece and an extension portion piece, and an adjustingtool. The support portion piece comprises a tissue support portion sizedand shaped for placement to support a urethra. The extension portionpiece comprises a proximal end, a distal end, and a tissue fastener, andis adjustably connected to the support portion piece at an adjustingengagement. The adjusting tool comprises a surface capable of engagingthe support portion piece, and a moveable holder capable of holding theproximal end of the extension portion piece and moving the proximal endrelative to the adjusting engagement.

In another aspect the invention relates to a system for treating apelvic condition such as urinary incontinence, the system comprising animplant and a tool. The implant comprising a support portion, twoextension portions, and two self-fixating tips, one self-fixating tip atan end of each extension portion, and a guide engaged with at least oneof the self-fixating tips. The tool includes a shaft having a distal endcapable of engaging the self-fixating tip, and a release mechanism atthe distal end, the release mechanism capable of selectively engagingand releasing the self-fixating tip. The shaft is capable of engagingthe guide to allow the shaft to be led along the guide to become engagedwith the self-fixating tip.

In another aspect the invention relates to a system for treating apelvic condition incontinence. The system includes an adjustable implantcomprising a support portion, two extension portions, and twoself-fixating tips. One self-fixating tip is located at an end of eachextension portion. At least one self-fixating tip is moveably engagedwith one of the two extension portions. The support portion being ismovable to adjust a location of the support portion along the implantbetween the self-fixating tips.

In another aspect the invention relates to a system for treating urinaryincontinence, the system comprising a multi-piece implant comprising asupport portion piece and two extension portion pieces, and an adjustingtool. The support portion piece comprises a tissue support portion sizedand shaped for placement to support a urethra. The extension portionpieces each comprise a proximal end, a distal end, and a tissuefastener. The first extension portion piece is adjustably connected tothe support portion piece at a first adjusting engagement. The secondextension portion piece is adjustably connected to the support portionpiece at a second adjusting engagement. The adjusting tool comprises twoadjusting surfaces, the two adjusting surfaces being capable of engagingthe support portion piece in a manner to place tension along a length ofthe support portion piece

In yet another aspect the invention relates to a system for treatingurinary incontinence, the system comprising an implant and a tool. Theimplant comprises a support portion, two extension portions, and aself-fixating tip at a distal end of each extension portion. The toolcomprises a proximal end and a distal end, a surface at the distal endcapable of approximating a urethra, two shafts that can be extended andretracted from the distal end, and an adjusting surface at each shaftdistal end, each adjusting surface being capable of engaging aself-fixating tip.

In another aspect the invention relates to a system for treating urinaryincontinence, the system comprising a multi-piece implant comprising asupport portion piece and an extension portion piece, and an adjustingtool. The support portion piece comprises a tissue support portion sizedand shaped for placement to support a urethra.

The extension portion piece comprises a proximal end, a distal end, anda tissue fastener, and is adjustably connected to the support portionpiece at an adjustable connection. The adjusting tool comprises asurface capable of engaging the support portion piece.

In another aspect the invention relates to a method of treating urinaryincontinence in a male or a female patient. The method includesproviding a system according as described herein, placing the implantbelow a urethra of the patient and placing tissue fasteners atsupportive tissue. Optionally the placement of the implant can beadjusted, the size of the implant or an extension portion can beadjusted, and the method can include using a tool to approximate tissueof the urethra.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an embodiment of a system as described, including atool and an implant.

FIGS. 2A, 2B, and 2C illustrate an exemplary method useful with adescribed system.

FIG. 3 illustrates an embodiment of a system as described, including atool and an implant.

FIGS. 4A, 4B, and 4C illustrate an exemplary method useful with adescribed system.

FIG. 5 illustrates an embodiment of a system as described, including atool and an implant.

FIGS. 6A, 6B, and 6C illustrate an exemplary method useful with adescribed system.

FIG. 7 illustrates an embodiment of a system as described, including atool and an implant.

FIGS. 8A, 8B, and 8C illustrate an exemplary method useful with adescribed system.

FIGS. 9A and 9B illustrate embodiments of systems as described,including a tool and an implant.

FIGS. 10A, 10B, and 10C illustrate an exemplary method useful with adescribed system.

FIG. 11 illustrates an embodiment of a system as described, including atool and an implant.

FIGS. 12A, 12B, and 12C illustrate an exemplary method useful with adescribed system.

FIG. 13 illustrates an embodiment of a system as described, including atool and an implant.

FIGS. 14A, 14B, and 14C illustrate an exemplary method useful with adescribed system.

FIG. 15 illustrates an embodiment of a system as described, including atool and an implant.

FIGS. 16A, 16B, and 16C illustrate an exemplary method useful with adescribed system.

FIGS. 17 A and 17B illustrate embodiments of systems as described,including tools and an implant.

FIGS. 18A, 18B, and 18C illustrate an exemplary method useful with adescribed system.

FIG. 19 illustrates an embodiment of a system as described, including atool and an implant.

FIG. 20 illustrates an embodiment of a system as described, including atool and an implant.

FIG. 21 illustrates an embodiment of a system as described, including atool and an implant.

FIG. 22 illustrates an embodiment of a system as described, including atool and an implant.

DETAILED DESCRIPTION

The systems, devices, tools, implants, etc., described herein aredirected to surgical instruments, assemblies, implantable articles,systems and related methods for treating urinary incontinence in a maleor female, including stress urinary incontinence (SUI). An implant canbe implanted in a male or a female to treat a condition such as urgeincontinence, mixed incontinence, overflow incontinence, functionalincontinence, and the like.

An implant can include a tissue support portion (or “support portion”)that can be used to support a urethra or other pelvic tissue. Supportinga “urethra” refers to supporting tissue that includes the urethra (whichcan refer to the bladder neck) and that can optionally include tissueadjacent to a urethra such as bulbospongiosus muscle, corpus spongiosum,or both. According to various methods, for example, a support portionmay either be placed below bulbospongiosus muscle to support bothulbospongiosus muscle and corpus spongiosum (along with the urethra), oralternately bulbospongiosus muscle may be dissected and a supportportion may be placed to contact corpus spongiosum tissue (to supportthe urethra).

An implant can additionally include one or more extension portion(otherwise known as an “end” portion or “arm”) attached or attachable tothe tissue support portion. Normally, for treating incontinence, animplant can include two opposing extension portions. Extension portionsare elongate pieces of material (e.g., mesh, suture, or biologicmaterial) that extend from the tissue support portion and either are orcan be connected to the tissue support portion, and are useful to attachto anatomical features or “supportive tissue” in the pelvic region(e.g., using a self-fixating tip or another form of tissue fastener) tothereby provide support for the tissue support portion and the supportedtissue. Generally for treating incontinence, two extension portions canextend from the opposite ends of a tissue support portion as elongate“ends,” “arms,” or “extensions,” and may attach to supportive tissue inthe pelvic region by extending through a tissue path to an internalanchoring point (see, e.g., Applicant's co-pending United States PatentApplication Publication number US 2010/256442, filed Aug. 8, 2008, byOgdahl, entitled SURGICAL ARTICLES AND METHODS FOR TREATING PELVICCONDITIONS, the entirety of which is incorporated herein by reference),or may extend to an external incision, such as through an obturatorforamen and through an external incision at a groin or inner thigh (see,e.g., Applicant's co-pending United States Patent Publication Number US2006/0287571, the entirety of which is incorporated herein byreference). Also see U.S. Patent Publication number US 2011/0034759 andWO 2010/093421, the entireties of which are incorporated hereby byreference.

In exemplary uses, each extension portion can extend from the locationof attachment with the tissue support portion, through pelvic tissue,and optionally be attached to supportive tissue within the pelvicregion. For certain procedures the supportive tissue can be tissueadjacent to the urethra such as pelvic fascia; tissue between theurethra and an obturator foramen such as pelvic fascia; or tissue of anobturator foramen such as obturator fascia, obturator internus muscle,obturator membrane, obturator externus muscle, etc. For alternateprocedures an extension portion can be sized to extend from the tissuesupport portion, through an obturator foramen, around a pubic ramusbone, and threaded (subcutaneously) back to a medial location such asnear a medial incision.

An implant may include portions, pieces, or sections that are syntheticor of biologic material (e.g., porcine, cadaveric, etc.). Extensionportions may be, e.g., a synthetic mesh such as a polypropylene mesh, asuture, a biodegradable suture, etc. The tissue support portion may besynthetic (e.g., a polypropylene mesh) or biologic. Examples of implantproducts that may be similar to those useful according to the presentdescription, include those sold commercially by American MedicalSystems, Inc., of Minnetonka Minn., under the trade names Apogee®,Perigee®, and Elevate® for use in treating pelvic prolapse (includingvaginal vault prolapse, cystocele, enterocele, etc.), and Spare®,Bioarc®, Monarc®, and MiniArc® for treating urinary incontinence.

An example of a particular type of pelvic implant is the type thatincludes supportive portions including or consisting of a tissue supportportion and two opposing extension portions extending from the tissuesupport portion. An implant that has exactly two extension portions canbe of the type useful for treating urinary incontinence. The term“supportive portions” refers to portions of an implant that function tosupport tissue after the implant has been implanted, and specificallyincludes extension portions and tissue support portions, and does notinclude optional or appurtenant features of an implant such as a sheath,tensioning suture, tissue fastener, or self-fixating tip or other typeof connector for attaching the implant to an insertion tool.

A preferred implant (e.g., sling) for placement against a corpusspongiosum for treatment of urinary incontinence in a male patient mayoptionally and preferably include a widened central support to provideincreased contact and frictional engagement with the corpus spongiosum.See, for example, Assignee's co-pending United States Patent PublicationNumber US 2006/0287571 and U.S. Pat. No. 7,422,557, the entireties ofthese applications being incorporated herein by reference.

Dimensions of a tissue support portion can be any dimensions useful tosupport urethra tissue for treating incontinence. A tissue supportportion can be of sufficient length to support and optionally partiallysurround a urethra or urethra-supporting tissue. A width of a tissuesupport portion may optionally and preferably be greater than a width ofextension portions and can be sufficiently wide to increase contact areaand frictional forces between a tissue support portion and a tissue incontact with the tissue support portion. Exemplary lengths of a tissuesupport portion can be in the range from 0.5 to 2 inches, such as from0.75 to 1.5 inches. Exemplary widths of a tissue support portion can bein the range from 0.4 or 0.5 to 4 centimeters, such as from 1 to 2.5 or3 centimeters. (A tissue support portion may be part of a supportportion piece that includes the tissue support portion and optionallysome amount of opposing extension portions extending from ends of thetissue support portion.

Dimensions of extension portions according to the invention can allowthe extension portion to reach between a tissue support portion placedto support a urethra (at an end of the extension portion connected tothe tissue support portion) and a location at which the distal end ofthe extension portion attaches to supportive tissue at or about thepelvic region. Exemplary lengths of an extension portion for theseembodiments, measured for example between a connection or boundarybetween the extension portion and the tissue support portion, and adistal end of the extension portion, can be, e.g., from 0.5 to 2.75inches, preferably from LO to 2.25 inches, and the length can optionallyand preferably be adjustable. As described elsewhere herein, a length ofan extension portion may be fixed (i.e., the extension portion does notinclude any form of length-adjusting mechanism). Alternate embodimentsof implants may include an adjusting engagement that allows a physicianto alter the length of an extension portion before, during, or afterimplantation.

Implants as described can include a tissue fastener at a distal end or adistal portion of an extension portion, which is the end or portion notattached to a tissue support portion. (The term «distal” as used herein(unless noted otherwise) generally refers to a direction toward apatient and away from a surgeon installing a device.) A tissue fastenerat a distal end or portion of an extension portion can be any of varioustypes, including: a self-fixating tip that is inserted into soft tissueand frictionally retained; soft tissue anchors; biologic adhesive; asoft tissue clamp that can generally include opposing, optionallybiased, jaws that close to grab tissue; and opposing male and femaleconnector elements that engage to secure an end of an extension portionto tissue. (See International Patent Application No. PCT/US2007/014120,entitled “Surgical Implants, Tools, and Methods for Treating PelvicConditions, filed Jun. 15, 2007; U.S. patent application Ser. No.12/223,846, filed Aug. 8, 2008, entitled SURGICAL ARTICLES AND METHODSFOR TREATING PELVIC CONDITIONS, now U.S. Publication No. 2010/0256442;U.S. patent application Ser. No. 12/669,099, filed Jan. 14, 2010,entitled PELVIC FLOOR TREATMENTS AND RELATED TOOLS AND IMPLANTS, nowU.S. Publication No. 2010/0261955; and WO 2009/075800, the entireties ofwhich are incorporated herein by reference.) An implant may also haveone or more extension portion that does not include a tissue fastener,for example if the distal end is designed to be secured to tissue byother methods (e.g., suturing), or is intended to pass through anobturator foramen and a tissue path around a pubic ramus bone, in whichcase the extension portion may optionally include a connector, dilator,or dilating connector, which connects to an elongate tool that can beused to either push or pull the connector, dilator, or dilatingconnector through a tissue path (e.g., to a medial incision).

One embodiment of a tissue fastener is a self-fixating tip. A“self-fixating tip” in general can be a structure (sometimes referred toas a soft tissue anchor) connected at a distal end of an extensionportion (or extension portion piece) that can be implanted into softtissue (e.g., muscle, fascia, ligament, etc.) in a manner that willmaintain the position of the self-fixating tip and support the attachedimplant. Exemplary self-fixating tips can also be designed to engage anend of an insertion tool (e.g., elongate needle, elongate tube, etc.) sothe insertion tool can be used to push the self-fixating tip through andinto tissue for implantation, preferably also through a medial incisionto reach the interior of the pelvic region, e.g., at a location of anobturator foramen. The insertion tool may engage the self-fixating tipat an internal channel of the self-fixating tip, at an external locationsuch as at an external surface of the base, at a lateral extension, orotherwise as desired, optionally in a manner to allow the insertion toolto push the self-fixating tip through an incision in a patient andthrough and into supportive tissue.

Exemplary self-fixating tips can include one or more lateral extensionsthat allow the self-fixating tip to be inserted into soft tissue and tobecome effectively anchored in the tissue. A lateral extension may bemoveable or fixed. The size of the self-fixating tip and optionallateral extensions can be useful to penetrate and become anchored intothe tissue. Exemplary self-fixating tips are described in Assignee'sco-pending international patent application PCTUS2007/004015, filed Feb.16, 2007, titled Surgical Articles and Methods for Treating PelvicConditions, the entirety of which is incorporated herein by reference.Other structures may also be useful.

According to exemplary embodiments, a self-fixating tip can havestructure that includes a base having a proximal base end and a distalbase end. The proximal base end can be connected (directly orindirectly, such as by a connective suture) to a distal end of anextension portion. The base extends from the proximal base end to thedistal base end and can optionally include an internal channel extendingfrom the proximal base end at least partially along a length of the basetoward the distal base end. The optional internal channel can bedesigned to interact with (i.e.; engage, optionally by means of arelease mechanism that can be selectively engaged and released) a distalend of an insertion tool to allow the insertion tool to be used to placethe self-fixating tip at a location within pelvic tissue of the patient.A self-fixating tip can be made out of any useful material, generallyincluding materials that can be molded or formed to a desired structureand connected to or attached to a distal end of an extension portion ofan implant. Useful materials can include plastics such as polyethylene,polypropylene, and other thermoplastic or thermoformable materials, aswell as metals, ceramics, and other types of biocompatible andoptionally bioabsorbable or bioresorbable materials. Exemplarybioabsorbable materials include, e.g., polyglycolic acid (PGA),polylactide (PLA), copolymers of PGA and PLA.

According to various systems as described, one or more instrument,insertion tool, adjusting tool, or the like, may be incorporated or usedwith the described implants and methods. Examples of useful toolsinclude those that generally include one or more (stationary ormoveable) thin elongate, relatively rigid shaft or needle that extendsfrom a handle. The shaft can be a single elongate shaft or multipleseparate elongate shafts extending from the handle, or one or moreprimary shaft that extends from the handle and that contains multiplebranch or “tine” shafts that separate at the end of the primary shaft.The handle is located at a proximal end of the device and attaches toone end (a proximal end) of a shaft. According to some embodiments, adistal end of one or more shaft can be adapted to engage a portion of animplant, such as a tissue fastener (e.g., a self-fixating tip), in amanner that allows the insertion tool to engage and push the tissuefastener through a tissue passage and connect the tissue fastener tosupportive tissue of the pelvic region. Examples of this type of toolcan be use<1 with a self-fixating tip that includes an internal channeldesigned to be engaged by a distal end of an insertion tool to allow theself-fixating tip to be pushed into tissue. Other general types ofinsertion tools will also be useful but may engage a self-fixating tipor other tissue fastener in an alternate manner, e.g., that does notinvolve an internal channel.

According to other embodiments, a distal end of a tool (e.g., at onemore shaft) can be adapted to engage one or more other portion of animplant, such as support portion, a proximal end of an extensionportion, or both. The insertion tool may manipulate a tissue supportportion and an extension portion of a multi-piece implant in a manner toallow the tool to adjust the size or positioning of the implant.

Exemplary insertion tools for treatment of incontinence and vaginalprolapse are described, e.g., in U.S. patent application Ser. No.10/834,943, now U.S. Pat. No. 7,500,945, Ser. No. 10/306,179, now U.S.Pat. No. 7,070,556; Ser. No. 11/347,553, now U.S. Pat. No. 7,422,557;Ser. No. 11/398,368, now U.S. Pat. No. 7,740,576; Ser. No. 10/840,646.now U.S. Pat. No. 7,351,197; PCT application number 2006/028828,published as WO 2007/016083; PCT application number 2006/0260618; WO2010/093421, and US Patent Publication No. 2010-0256442 the entirety ofthese documents being incorporated herein by reference.

A tool according to the invention can optionally include a mechanism bywhich a tissue fastener (e.g., a self-fixating tip) can be securely andreleasable engaged with a distal end of an insertion tool such that thetissue fastener can be selectively secured to the distal endmechanically, then selectively released. With a releasable engagement, atissue fastener (e.g., self-fixating tip) can be released from thedistal end by releasing the engagement (e.g., mechanical engagement) bymovement of an actuator at the proximal end of the insertion tool, suchas at the handle. For example, an internal channel (or external surface)of a self-fixating tip can include an engaging surface designed toengage a mechanism at a distal end of an insertion tool while theself-fixating tip is placed at, on, or over the distal end. As anexample, an internal or external surface of a self-fixating tip caninclude a depression, ring, edge, or ledge, that can be rounded,angular, etc. A mechanical detent such as a pin, ball, spring,deflector, or other surface or extension located at the distal end ofthe insertion tool can be moved, deflected, or extended relative to thedistal end of the insertion tool to contact the surface of theself-fixating tip to securely and releasably hold the self-fixating tipat the distal end of the insertion tool and prevent removal of the tipfrom the distal end until removal is desired. The detent (or othersurface or mechanism) can be cause to extend (or retract) from thedistal end of the insertion tool by actuating a trigger or othermechanism located at the proximal end (e.g., handle or a proximallocation of a shaft) of the insertion tool, to secure (or release) theself-fixating tip. Upon placement of the self-fixating tip at a desiredlocation during a surgical implantation procedure, the insertion tooloperator can release the self-fixating tip by use of the trigger orother mechanism at the handle to disengage the detent and cause the tipto become loose. The insertion tool can then be removed from the tissuepath, and the self-fixating tip can remain in a desired implantedlocation.

Optionally, an implant can include a tissue fastener at a location of atissue support portion, or at a location along a length of an extensionportion. This form of tissue fastener can be in the form of reinforced(e.g., by coating, heat treating, or a reinforcing weave or strip) edgeextensions, multiple layers of mesh and edge extensions in an extensionportion, etc., as described, for example, at Applicant's co-pending U.S.Pat. No. 7,422,557, and Applicant's co-pending United States PatentPublication Numbers US 2006/0195011, US 2006/0195007, and US2006/0195010, all of which are incorporated herein by reference. Otherexamples include relatively rigid structures such as metal, plastic, orother polymeric or non-polymeric structure that may be shaped tofrictionally engage soft tissue, for example to include a tine, hook,chevron, barb, arrow, etc., combinations thereof, or any structure addedto an edge or surface of an extension portion to improve fixation withintissue. The structure can have any shape or form that will increasefrictional force between the. implant and adjacent tissue, such as oneor multiple pointed surface directed along a length of an extensionportion, toward the tissue support portion, and extending away from asurface or edge of the implant (e.g., extension portion). The tissuefastener can be located at a position of an implant that will result inthe tissue fastener being located at supportive tissue such as muscle orfascia when the implant is placed with a midline of the tissue supportportion being located below a urethra. For example, a tissue fastenermay be located on a tissue support portion or an extension portion of animplant, e.g., as close as 2 or 3 centimeters from a midline of a tissuesupport portion, and up to a distance that reaches tissue of anobturator foramen when the midline is located below a urethra, e.g., upto 7 centimeters from the midline.

According to various embodiments of implants described herein, animplant can include multiple pieces that are adjustably connectedtogether by an adjusting engagement. A “multi-piece” implant refers toan implant that includes a “support portion piece” and one or multiple“extension portion piece” as separate pieces of the implant. Anextension portion piece can be separate from a support portion piece,and the two pieces can be connected through an adjustable engagement.The support portion piece includes a tissue support portion.

An adjusting engagement may be for example a one-way adjustingengagement, a two-way adjusting engagement, or a locking two-wayengagement, that allows a portion, piece, or a segment of an implant tobe moved relative to another portion, piece, or segment if the implantand adjusted as to length, tension, or positioning. Examples ofadjusting engagements are described, for example, in Applicant'sco-pending U.S. patent application Ser. No. 12/308,436, filed Dec. 15,2008, entitled SURGICAL IMPLANTS AND TOOLS FOR TREATING PELVICCONDITIONS, now U.S. Publication No. 2011/0112357, and U.S. patentapplication Ser. No. 12/669,099, filed Jan. 14, 2010, entitled PELVICFLOOR TREATMENTS AND RELATED TOOLS AND IMPLANTS, now U.S. PublicationNo. 2010/0261955, the entireties of which are incorporated herein byreference.

Some adjusting engagements can allow two-way movement of one piecerelative to another piece (e.g., a “two-way” adjusting engagement). Thistype of adjusting engagement allows movement of a segment of implant(e.g., of a segment or portion of an extension portion piece) in twodirections through an adjusting engagement. The force needed to move thesegment of implant in one direction is substantially equal to the forceneeded to move the segment in the opposite direction, and, optionally,the two-way adjusting engagement does not substantially hinder themovement of a segment of implant through the adjusting engagement withfrictional surfaces such as extensions (e.g., “teeth”) extending into anaperture through which the segment of implant is moved. As an example, atwo-way adjusting engagement may include an open (smooth) aperture thatmay be circular, oval, square, elongate, or rectangular, such as in theform of a circle, slit, or slot, etc. The aperture may optionally bereinforced by a reinforced perimeter of a shape that is similar to theaperture, such as by a fabric or a polymeric material such as a grommet(e.g., a “loose grommet” or “eyelet”), which may be circular, square,rectangular, or of any desired shape. The reinforced perimeter (e.g.,grommet) defines a reinforced aperture through which a segment ofimplant can pass relatively freely and with the same resistance twodifferent directions

A two-way adjusting engagement may optionally be capable of an open anda closed (e.g., locked) configuration, the open configuration allowingtwo-way movement between the pieces, and the closed (or locked)configuration preventing any movement between the pieces. Such anadjusting engagement may be referred to as a locking two-way adjustingengagement and may include any form of mechanical securement device thatcan be configured in an open configuration (to allow two-way movementbetween pieces) and a closed configuration (to prevent movement betweenpieces). The locking two-way adjusting engagement may be selectively andreversibly moveable between the open configuration and the closedconfiguration or may instead initially be an open configuration that,once placed in a closed configuration, cannot be re-configured to theopen configuration. Examples of structures that may be part of a lockingtwo-way adjusting engagement include a mechanical clip, staple, stitch,detent, or rivet; any form of spring-loaded or moveable frictionalengagement; a non-moveable frictional engagement such as a slot, slit,cleat, or other non-moveable aperture or opening through which a portionof implant can be selectively engaged, released, and re-engaged; adeformable opening, ring, clip, staple, etc., which may be generallyopen and then permanently closed by mechanical deformation; and thelike. One form of exemplary structure may be forceably closed (e.g. bybending a part until permanent deformation or closing a part until somelatch or similar feature snaps shut), while others may be biased toclose (e.g. a spring-loaded clip is held open until released so it canclamp shut). Changing from an open to a closed orientation could beperformed by an independent tool or may be an additional feature builtinto the adjustment tool. The clip or alternate opening-closingstructure could be attached to larger structure of an adjustingengagement (potentially integrated into its design), or separate (so itcould be loaded into the tool).

Other adjusting engagements may allow for one-way adjustment such asshortening of a length of an extension portion. These adjustingengagements can be referred to as “one-way” adjusting engagements andallow adjustment of a length of an implant portion (e.g., extensionportion) in one direction and not (or not easily) in an oppositedirection. An exemplary one-way adjusting engagement can include anaperture through which a segment of implant (e.g., a portion of anextension portion piece) can extend, and one or multiple surfaces (e.g.,extensions or teeth) that frictionally engage the segment of implantpassing therethrough, e.g., by extending into or toward the aperture orotherwise contacting the segment of implant to inhibit movement of thesegment of implant relative to the adjusting engagement. The one-wayengagement can preferentially allow movement of the segment of implantthrough the aperture in one direction while inhibiting or preventingmovement of the segment of implant in an opposing direction.

In use of a tissue support portion that includes a one-way adjustingengagement such as a round or rectangular grommet, a tissue fastener(e.g., a self-fixating tip) at one end of an extension portion is placedat tissue as desired, and the second (loose) end of the extensionportion piece is passed through the one-way adjusting engagement. Theengagement is adjusted to place the support portion piece at a desiredposition (length) of the extension portion piece to provide desiredsupport to a urethra. The one-way adjusting engagement moves easilyalong the extension portion piece in a direction that tightens theimplant against urethra tissue and does not move easily in the oppositedirection. Once placed in position below the urethra and tightened asdesired, the support portion piece is prevented from moving along theextension portion piece in the direction to reduce support of theurethra. The extension portion piece may optionally be considered to be“smooth,” without any visible:frictional surface, or may alternatelyinclude bumps, detents, teeth, a jagged surface, or other frictional ormechanical structure to engage opposing structure at a surface of anaperture of the one-way adjusting engagement.

FIG. 1 illustrates a system that includes implant 22 (e.g., for treatingmale or female urinary incontinence) and insertion tool 10. Implant 22includes support portion 24, end or extension portions 26, andself-fixating tips 28. Guide collars 30 are engaged with each ofself-fixating tips 28. Insertion tool 10 includes shaft 12, distal end14, proximal end and handle 20, release mechanism (e.g., comprisingdetents, teeth, or extensions) 16, and trigger 18 located at a proximalregion of shaft 12. Trigger 18 can activate and de-activate releasemechanism 16 to selectively securely engage and release self-fixatingtip 28, relative to distal end 14.

FIG. 1 additionally shows a feature of two guides (e.g., guide tubes)30, each guide being removably engaged with one of the two self-fixatingtips 28. Each guide 30 allows a user to move a distal end of shaft of aninsertion tool (e.g., 10) into engagement with a self-fixating tip(e.g., 28). In specific, guide 30 is in the form of a hollow guide tube,having an elongate hollow shaft and two ends, one opening at each end. Adistal end opening engages a channel or bore of self-fixating tip 28.The distal end removably engages self-fixating tip 28 through anyremovable or disengageable structure, such as a threaded engagement, aperforated engagement, a frictional engagement, or any other form ofengagement that can be broken, disrupted, or disengaged by a separatemechanical mechanism located on tool 10, e.g., between proximal handle20 and distal end 14.

During use, a distal end of an insertion tool (e.g., distal end 14) canbe inserted into a proximal end of a guide tube and guided through theguide tube to engage self-fixating tip 28. The guide allows the distalend to engage the self-fixating tip while the self-fixating tip isengaged with the guide. This allows the distal end to engage theself-fixating tip outside of the patient so a surgeon can use theinsertion tool to initially place the self-fixating tip through a medialincision and into engagement with supportive tissue. The initialplacement may first be performed, after which the shaft and distal endmay be removed from the guide and the patient, and the placement andtension of the self-fixating tip and implant may be tested to determineif adjustment is necessary. If so, the distal end and shaft may bere-engaged with the self-fixating tip previously placed at the tissue byre-inserting the distal end into the guide (which is accessible, e.g., aproximal end can remain outside of the patient) and passing the distalend through the guide to re-engage the distal end with the self-fixatingtip. The guide leads the distal end to the self-fixating tip, and thedistal end can re-engage the self-fixating tip. The insertion tool canthen be used to push the self-fixating tip to a location of deeperpenetration into the tissue.

After desired placement of the self-fixating tip, followed bydisengagement and optional re-engagement of an insertion tool with theinitially-placed self-fixating tip, and adjustment, the insertion toolcan be removed from the guide and the guide can be removed from theself-fixating tip (optionally while the distal end is engaged with theself-fixating tip).

FIGS. 2A, 2B, and 2C, illustrate a method of using tool 10 to placeimplant 22, with guides 30, to treat urinary incontinence. Patientanatomy includes a medial (e.g., perineal) incision (not shown), alocation of a urethra (not shown) and corpus spongiosum 32, corpuscavemosa 36 and pubic ramus bones 34, which bound an obturator foramen(not shown). A distal end of insertion tool 10, passed through guidetube 30 and engaged with self-fixating tip 28, is used to insertself-fixating tip 28 through a medial (e.g., perineal or vaginal)incision and place self-fixating tip 28 at supportive tissue in a regionof an obturator foramen on a first side of the patient. See FIG. 2A.Insertion tool 10 is then withdrawn from self-fixating tip 28 and guidetube 30. Release mechanism 16 (e.g., detents) at distal end 14 can beselectively engaged and released as desired. For example, self-fixatingtip 28 can be placed in supportive tissue with release mechanismactivated to secure tip 28 at distal end 14 and can be de-activated todisengage distal end 14 from self-fixating tip 28 after placement of thetip, followed by withdrawal of shaft 12 away from self-fixating tip 28and back out of guide tube 30.

As then shown at FIG. 2B, tool 10 can be used to engage the secondself-fixating tip 28 of implant 22, through second guide tube 30, andthe second self-fixating tip 28 can be placed at supportive tissue in aregion of an obturator foramen on a second side of the patient. Tool 10can optionally be disengaged (by use of trigger 18) from self-fixatingtip 28 and withdrawn from guide tube 30. Optionally tool 10 may be usedto adjust the position (e.g., depth) of one or both of self-fixatingtips 28 within supportive tissue by re-engaging one or both ofself-fixating tips (28) through guide 30 to then push a self-fixatingtip 28 to a deeper location within the supportive tissue. The opening atthe distal end of each guide tube can be accessible, e.g., extends to alocation outside of the patient, while the proximal end of the guidetube and the attached self-fixating tip (28) are located within thesupportive tissue (e.g., at a region of an obturator foramen). Uponfinal adjustment, each of guide tubes 30 can be removed fromself-fixating tips 28 and the patient. Removal of a guide tube 30 canoptionally be performed with assistance of insertion tool 10. Forexample, to remove a guide tube 30 from a self-fixating tip, tool 10 canbe re-inserted into the guide tube and re-engaged with the self-fixatingtip. The tool can engage the self-fixating tip to hold the tip at itslocation within supportive tissue and prevent undesired (proximal)forces from being applied to the properly-placed self-fixating tip whilepressure is placed on the guide tube to separate the guide tube from theself-fixating tip.

FIG. 3 illustrates a system that includes implant 52 (e.g., for treatingmale or female urinary incontinence) and insertion tool 50. Implant 52includes support portion 54, two opposing end or extension portions 56,and self-fixating tips 58. Support portion 54 is moveable along thelength of the implant between self-fixating tips 58. One of the selffixating tips includes a tightening buckle 60 through which extensionportion 56 can be threaded and frictionally engaged. Tightening buckle60 includes two frictional surfaces, one hinged frictional surface 64and a second non-hinged frictional surface 62. As illustrated,frictional surface 62 is stationary and frictional surface 64 is hingedto form a frictional engagement that allows for loose end 51 of implant52 to be pulled (proximally) away from buckle 60, after which, buckle 60inhibits movement in an opposite direction. In use, a length ofextension portion 56 can be threaded initially through hinged loop 68and stationary loop 66 (see inset at FIG. 3, lower image), adjacent tohinged surface 64 and stationary surface 62, respectively. Extensionportion 56 is then threaded back and over stationary frictional surface62 (outside of loop 66), past hinged frictional surface 64 and throughhinged loop 68, to contact the portion of extension portion 56 enteringhinged loop 68, then back in a proximal direction (now referred to asloose end 51). Loose end 51 can be pulled to shorten the length ofimplant located between the two self-fixating tips 58 and to produce ataught length of implant supporting a urethra, after which buckle 60inhibits loosening or lengthening of the implant within the patient.

Tool 50 includes handle 40, shaft 42, and distal end 44 capable ofengaging an aperture of each of self-fixating tips 88. Tool 50 is notspecifically illustrated to include a release mechanism like thatdescribed with respect to tool 10, but tool 50 could optionally includea release mechanism.

FIGS. 4A, 4B, and 4C, illustrate a method of using tool 50 to placeimplant 52, having tightening buckle 60 at one end of an extensionportion, and adjustable support portion location, to treat urinaryincontinence. Patient anatomy is as described previously. A distal endof insertion tool 50, engaged with self-fixating tip 58, is used toinsert self-fixating tip 58 through a medial incision and placeself-fixating tip 58 at supportive tissue in a region of an obturatorforamen on a: first side of the patient. See FIG. 4A. Insertion tool 50is then used to engage the second self-fixating tip 58 for placement ofthe second self-fixating tip 58 at supportive tissue in a region of anobturator foramen on a second side of the patient. Loose end 51 can beaccessible (e.g., can extend out of the medial incision) and can bepulled (proximally) to adjust a length of implant between self-fixatingtips 58, to provide desired tension on the length of implant, anddesired approximation; placement, and support of the urethra. See FIG.4B. Loose end 51 can then be removed by cutting. See FIG. 4C. Before,after, or simultaneously with tightening the length of implant bypulling loose end 51, moveable support portion 54 can be moved (slid) ina direction toward one or the other obturator foramen to place moveablesupport portion 54 at a desired (central, medial) location below theurethra.

FIG. 5 illustrates a system that includes implant 73 (e.g. for treatingmale or female urinary incontinence) and insertion tool 80. Implant 73includes support portion 84, end or extension portions 86, andself-fixating tips 88. Support portion 84 is moveable along the lengthof the implant between self-fixating tips 88. Extension portions 86extend through supports (or guides, having apertures) 85 located onsupport portion 84, allowing each support (or guide) 85 of supportportion 84 to be moved and positioned at a desired location along alength of each extension portion 86. The effect is to allow a user toreduce or increase (i.e., lengthen) the effective size of each extensionportion by sliding each support 85 toward a respective self-fixating tip88, on one or both sides of the implant and patient, thereby reducingthe overall length of implant 73 between self-fixating tips 88. Support(guide) 85 supports extension portion 86 by means of a one-way or atwo-way adjusting engagement.

Upon desired adjustment, locking disk 92 can be moved distally (towardthe patient and toward support portion 84 and self-fixating tips 88)along proximal portions (or loop) 76 of extension portions 86, to securethe location of support portion 84 relative to extension portions 86.Locking disk 92 can be frictionally secured to proximal portions 76 toprevent movement of support portion 84 relative to extension portions 86after desired placement of locking disk 92 relative to proximal portions76. Optionally an adjusting tool 90 (or “disk pusher tool” 90) can beused to push disk 92 along lengths of proximal portions 76 and towardsupport portion 84. Proximal portions 76 can be threaded throughaperture 96 at a distal end of tool 90, and distal surface 94, whichsurrounds aperture 96, can contact a proximal surface of disk 92 to pushdisk 92 distally along proximal portions 76 and toward support portion84.

Tool 80 includes handle 81, shaft 83, and distal end 89 capable ofengaging an aperture of each of self-fixating tips 88. Tool 80 is notillustrated to include a release mechanism like that described withrespect to tool 10, but tool 80 could 20 optionally include a releasemechanism.

FIGS. 6A, 6B, and 6C, illustrate a method of using tools 80 and 90 toplace implant 73, having adjustable support portion 84 andadjustable-length extension portions 86, to treat urinary incontinence.Patient anatomy is as described previously. Distal end 89 of insertiontool 80, engaged with self-fixating tip 88, is 25 used to insertself-fixating tip 88 through a medial incision and place self-fixatingtip 88 at supportive tissue in a region of an obturator foramen on afirst side of the patient. See FIG. 6A. Insertion tool 80 is then usedto engage the second self-fixating tip 88, and the second self-fixatingtip 88 can be placed at supportive tissue in a region of an obturatorforamen on a second side of the patient. Proximal 30 portions 76 can bepulled or tensioned (optionally with insertion tool 80 engaged with aself-fixating tip 88, to prevent force being placed on the self-fixatingtip) while adjustable support portion 84 is advanced distally toward thepatient to adjust a lengths of extension portions 86 and the lengthimplant between self-fixating tips 88, and to provide desired tension onthe length of implant and desired approximation, placement, and supportof the urethra. See FIG. 6B. Locking disk 92 (a one-way adjustingengagement relative) can be moved (e.g., slid) distally toward thepatient to frictionally engage proximal portions 76 to maintain theposition of adjustable support portion 84 relative to extension portions86 and the urethra. Disk pusher tool 90 can be used to move locking disk92. Proximal portions 76 can be removed by cutting. See FIG. 6C.

Embodiments of systems, kits, methods, and devices as described alsoinclude adjusting tools for simultaneously contacting two surfaces of animplant, especially two spaced surfaces of a support portion piece,e.g., to manipulate or stabilize the support portion piece, to allowadjustment of extension portion pieces relative to the support portionpiece. Preferred tools can include two adjusting surfaces that arecapable of concurrently (e.g., simultaneously) contacting two spacedsurfaces of a support portion piece, each of the two surfaces of thesupport portion piece being part of, at, or adjacent to a component ofan adjusting engagement, e.g., a one-way adjusting engagement or atwo-way adjusting engagement that can be closed or locked.

An adjusting tool can include any useful structure to support theadjusting surfaces of the adjusting tool, such as a handle (optional) ata proximal end, a shaft or multiple shafts extending from the handle, oralternate forms of support for the adjusting surfaces. An adjustingsurface can be any surface that can contact or otherwise engage asurface of an implant or a component of an implant. Optionally anadjusting surface can be a structure that defines an aperture, slot,opening, channel, peg, slit, extension, insert, or other surface that issized to engage a opposing or complementary component or surface of asingle piece or a multi-piece implant, e.g., an extension portion piece(e.g., a proximal end of an extension portion piece), a support portionpiece, or a tissue fastener (e.g., a self-fixating tip). Adjustingsurfaces of an adjusting tool can be spaced from each other by adistance that will allow simultaneous contact with two locations onopposing sides of an implant during use of the adjusting tool toposition and optionally adjust the position of the implant relative tourethral tissue being supported. For example, adjusting surfaces may belocated on a line that is perpendicular to an axis of a shaft of anadjusting tool, or that is perpendicular to a line parallel to an axisof a shaft of a tool, and may be spaced by a distance in the range of0.5 to 10 centimeters, such as a distance in the range from 2 to 8centimeters or from 2 to 6 centimeters (depending on the locations ofthe implant that the adjusting surfaces are intended to contact).Optionally, the adjusting surfaces can be either stationary or moveable(e.g., extendable away from another component of the adjusting tool suchas a handle or a primary shaft.

In certain embodiments, each of two adjusting surfaces can be located atan end of a single or of two separate shafts extending from a handle. Inparticular embodiments a single (e.g., primary) shaft may extend from ahandle, two separate tines or extensions can extend in differentdirections from the single shaft at a distal location, and one adjustingsurface can be at an end of each tine (or “extension”). For example, anadjusting tool may include a handle, a single shaft, and a “yoke” fixedor movably located at a distal end of the shaft; the yoke can extend intwo directions from the shaft and can include one adjusting surface atthe end of each extension. A line that connects the adjusting surfacesmay be located to intersect a longitudinal axis of the shaft (the shaft,shaft extensions, and adjusting surfaces are contained in a singleplane), or, in alternate embodiments, a line that connects the adjustingsurfaces may be located to not intersect a longitudinal axis of theshaft (the shaft, shaft extensions, and adjusting surfaces are notcontained in a single plane).

The adjusting surfaces can optionally be fixed or may be moveable, e.g.,relative to a shaft or a handle of the tool. The adjusting surfaces maybe fixed or may be capable of being moved relative to a shaft or handlein a manner to allow the adjusting surfaces to contact and adjust animplant by contacting opposite ends of an implant (oppositeself-fixating tips) or opposite ends of a piece of an implant (e.g., asupport portion piece or an extension portion piece) simultaneously. Forexample, the adjusting tool may include a handle, a single shaft, and a“yoke” that can be stationary or that can be moved along a length of theshaft, the yoke extending in two directions from the shaft and includingone adjusting surface at the end of each extension.

A distal end of a handle, shaft, or other feature of an insertion oradjusting tool may optionally be designed to contact tissue of a urethrato assist in approximating the urethra. For example, a distal end of ahandle or a shaft may optionally be adapted to contact a urethra duringplacement or adjustment of an implant, for example by having a curved(e.g., concave) or a flat surface that approximates or matches a shapeof a surface of urethral tissue (e.g., at a bulbospongiosus muscle or acorpus spongiosum) to be supported by the tissue support portion of theimplant being adjusted.

FIG. 7 illustrates a system for treating urinary incontinence, thesystem comprising a multi-piece implant and an adjusting tool thatincludes two distal adjusting surfaces. Adjusting tool 96 includeshandle 97, shaft 98 extending from a proximal shaft end at handle 97 tojunction 95 where the distal end of shaft 98 meets yoke (alternatelyopposing “yoke extensions”) 99 extending in two directions away fromshaft 98. Yoke 99 includes opening (or “gap”) 104 between its opposingextensions. Each of the two distal ends of each yoke extension 99includes adjusting surface 102 that includes an extension (or “prong” or“insert” directed laterally) that is capable of engaging receiver 100.

Each receiver 100 is located at an end of adjustable support portionpiece 106 and includes structure to receive adjusting surface 102 aswell as a component, portion, or feature of extension portion piece 110.As shown, extension portion piece 110 includes a mesh portion 114, anon-mesh portion 112, and a self-fixating tip 116. Non-mesh portion 112includes structure that frictionally engages receiver 100 to provide anadjusting engagement as described herein, e.g., a one-way or a two-wayadjusting engagement. As illustrated, non-mesh portion 112 includes aslotted or apertured tab that has openings, slots, apertures, orsurfaces that engage a one-way ratcheting structure of receiver 100. Thedistance of separation of surfaces 102 is about equal to the distance ofseparation of receivers 100, which is approximately the same as thelength of support portion 106. To engage the two surfaces 102 of the twoopposing yoke extensions 99 with each of the two receivers 100, onesurface 102 can be initially inserted into one receiver 100. Yoke 99 canbe squeezed together, e.g., by hand, to allow the spacing betweensurfaces 102 to be reduced, so the second surface 102 can be insertedinto second receiver 100. Yoke 99 can be removed from the two receivers100 in the same manner. The system also includes one or more insertiontool (e.g., 10, 50, or 80) (not shown) for engaging self-fixation tips116 for placing self-fixating tips 116 into supportive tissue.

FIGS. 8A, 8B, and 8C, illustrate a method of using tool 96 and aninsertion tool (e.g. 10) to place a three-piece implant havingadjustable support portion piece 106 and two extension portion pieces110, to treat urinary incontinence. Patient anatomy is as describedpreviously. A distal end of an insertion tool (e.g., 10, not shown),engaged with self-fixating tip 116, is used to insert self-fixating tip116 through a medial incision and at supportive tissue in a region of anobturator foramen on a first side of the patient. See FIG. 8A. Theinsertion tool is then used to engage the second self-fixating tip 116and place the second self-fixating tip 116 at supportive tissue in aregion of an obturator foramen on a second side of the patient.

Non-mesh portions 112 are inserted, one each, into each of the tworeceivers 100, to assemble an adjusting engagement between receiver 100and non-mesh portions 112. Adjusting surfaces 102 of tool 96 are theninserted (e.g., with squeezing together of yoke extensions 99) intoreceivers 100. See FIG. 8B. Each non-mesh portion 112 can be pulledthrough receiver 100, while tool 96 is used to advance adjustablesupport portion 84 distally, toward the patient, to adjust lengths ofextension portion pieces 110 extending from each receiver 100 toself-fixating tips 116, and to adjust the length of implant between thetwo self-fixating tips 116, and to provide desired tension on the lengthof implant and desired approximation, placement, and support of theurethra. See FIGS. 8B and 8C. Tool 96 can be removed, again by squeezingyoke extensions 99 together, allowing surfaces 102 to be removed fromreceivers 100. Non-mesh portions 112 can be removed by cutting.

FIG. 9A illustrates a system for treating urinary incontinence, thesystem comprising a multi-piece implant and a tool that includes twodistal adjusting surfaces. Adjusting tool 117 includes handle 160 thatincludes thumb ring 164 and two finger rings 162˜Shaft 118 extends froma proximal shaft end at handle 117, to surface 158, which includes twoadjusting surfaces 132 defined adjacent to apertures 133. Curved andlateral surface 158 extending between apertures 133 is sized and shapedto contact and assist in approximating tissue of a urethra (e.g., corpusspongiosum, bulbospongiosus muscle, etc.) during use of tool 117 toplace an implant to support the urethra. Secondary shafts 155 extendalongside primary shaft 118. A distal end of each secondary shaft 155includes snap-fit component 154, capable of receiving complementarysnap-fit feature 150 of a proximal end of extension portion piece 170.Shaft 118 and thumb ring 164 are moveable longitudinally relative tofinger rings 162, the movement being controlled by a ratchetingmechanism involving teeth 119 and reversible, lockable ratchet switch156. Secondary shafts 155 are secured to finger rings 162 and will movevvi.th finger rings 162 as finger rings 162 are moved longitudinallyalong primary shaft 118.

A multi-piece implant includes support portion piece 126 and twoextension portion pieces 170. Extension portion pieces 170 include amesh portion 144, a non-mesh portion (or “adjustment portion”) 142, aself-fixating tip 146, and a male snapfit component 150, which canengage female snap-fit component 154. Support portion piece 126 includesa surface to support a urethra and two apertures 130; each aperture 130can be a component of an adjusting engagement with non-mesh portion 142,e.g., a grommet or other one-way (or two-way, locking) frictionalengagement.

As illustrated extension portion piece 1 70 and a distal end of eachsecondary shaft 155 include opposing snap-fit components to allow theextension portion piece and secondary shaft to be snap-fitted together;any alternative type of connection (e.g., a non-snap-fit mechanicalengagement such as a thread, ratchet, etc.) would also be useful. Alsoas illustrated, snap fit component 154 is a female component (aperture)and snap-fit component 150 is a male snap-fit component (insertable intothe aperture of snap-fit component 154). Alternate arrangements wouldalso be useful. Non-mesh portions 142 include structure thatfrictionally engages aperture 130 to provide an adjusting engagementbetween aperture 130 and non-mesh portion 142, the adjusting engagementbeing, e.g., a one-way or a two-way adjusting engagement. Asillustrated, non-mesh portion 112 includes a polymeric rod that hassurfaces that engage a one-way frictional structure (e.g., grommet) ateach aperture 130. The non-mesh portion of this or any other embodimentmay alternately be a mesh material or an alternate form of a mesh or anon-mesh material, such a perforated strip, a slotted strip, a tubularmesh material, or a standard mesh (e.g., mesh strip or mesh tape). Atubular mesh material may be a mesh formed, in any manner, into a tube,such as being woven or knitted into tubular form, or treated with heat(e.g., thermoformed, melted) to form a tubular mesh.

In use, after placing each extension portion piece 170 at a desiredpatient location, e.g., with self-fixating tips 146 at supportivetissue, support portion piece 126 can be placed over distal surface 158of tool 117 with apertures 130 seated against apertures 133. Proximalends of extension portion pieces 170 can be passed through aperture 130and aperture 133 and engaged with aperture 154 of secondary shaft 155. Auser can grasp handle 160 with fingers in finger rings 162 and a thumbat thumb ring 164. Movement of finger rings 162 toward thumb ring 164causes finger rings 162 to move in a proximal direction relative to (andtoward) thumb ring 164. Simultaneously, secondary shafts 154 moveproximally relative to primary shaft 118, distal surface 158, andsupport portion piece 126. In turn, extension portion pieces 170(engaged with secondary shafts 154) are pulled in a proximal directionrelative to support portion piece 126. Surface 158, in contact withsupport portion piece 126, can be inserted through the medial incisionto contact tissue of a region of a urethra, to push or otherwise contactor place pressure on the urethra, to assist in approximating theurethra. The extension portion pieces can then be drawn throughapertures 130 (using the tool as described) to adjust the length of theextension portions and the location of the tissue support portion.

FIGS. 10A, 10B, and 10C, illustrate a method of using tool 117 and aninsertion tool (e.g. 10) to place a three-piece implant havingadjustable support portion piece 126 and two extension portion pieces170 to treat urinary incontinence. Patient anatomy is as describedpreviously. A distal end of an insertion tool (e.g., 10, not shown),engaged with self-fixating tip 146, is used to insert self-fixating tip146 through a medial incision and at supportive tissue in a region of anobturator foramen on a first side of the patient. See FIG. 10A. Theinsertion tool is then used to place the second self-fixating tip 116 atsupportive tissue in a region of an obturator foramen on a second sideof the patient.

Non-mesh portions 142 are inserted, one each, through apertures 130 and133, and snap-fit component 150 is engaged with aperture 154. See FIG.10B. Finger rings 162 are moved proximally, toward thumb ring 164, tocause secondary shafts 154 move proximally relative to primary shaft118. Proximal ends of extension portion pieces 170 (engaged withsecondary shafts 154) are pulled in a proximal direction relative tosupport portion piece 126. Surface 158, in contact with support portionpiece 126, can contact tissue of a region of a urethra approximate theurethra. Extension portion pieces 170 are drawn through apertures 130 toadjust the lengths of the extension portions 144 and the location oftissue support portion 126. See FIG. 10C. Upon desired placement of theassembled implant and urethra, tool 117 can be removed by cutting aproximal location of each support portion piece 1 70, e.g., mesh portionor non-mesh portion of support portion piece 170 that has become locatedon a proximal side of aperture 130.

FIG. 9B shows tool 117 and a multi-piece implant, as shown at FIG. 9A,with modifications as follows. Non-mesh portion 142 is a suture that canbe threaded collet 133 (or another form of locking two-way adjustingengagement) and suture adjustment and lock 161. Tube 131 seats againstcollet 133, with locking collet engagement 130; all are near surface 132and capable of maintaining the position of collets 130 of supportportion piece 126 near surface 158. Suture adjustment and lock 161 is alocking or closeable two-way adjusting engagement that can be opened (toform an open two-way adjusting engagement) and closed (to lock non-meshportion 142 relative to finger rings 162). In use, tube 131 is insertedin a distal direction into locking collet engagement 130, opening collet133 (see inset). With suture adjustment and lock 161 (both of these) inopen configurations, non-mesh portion 142 can be freely moved througheach suture adjustment and lock 161. Suture adjustment and lock 161 canbe closed to lock suture 142 relative to finger rings 162. Tool 160 canbe used to pull non-mesh portions 142 in a proximal direction to adjustthe size and position of the implant and urethra. Upon properadjustment, tube 131 can be removed from collet engagement 130, closingcollet 133 and fixing the position of non mesh portion 142 relative tosupport portion piece 126. Suture adjustment and lock 161 (both ofthese) can be opened to allow two-way movement of non-mesh portion 142therethrough, and tool 117 can be removed proximally.

FIG. 11 illustrates a system for treating urinary incontinence, thesystem comprising a single-piece implant and a tool that includes twodistal adjusting surfaces, each adjusting surface attached to a separateshaft that is moveable (extendable and retractable) relative to thetool. Tool 188 includes handle 174 and primary shaft 176. Handle 174extends from a proximal end to surface 186 useful for contacting tissue.Two adjusting surfaces 204 are located at distal ends of moveable shafts198. Each adjusting surface is capable of engaging a tissue fastenersuch as a self-fixating tip. Surface 186 extending laterally withinspace between shafts 198 is sized and shaped to contact and assist inapproximating tissue of a urethra (e.g., corpus spongiosum,bulbospongiosus muscle, etc.). Shafts 198 are moveable (extendable andretractable) relative to handle 174 and surface 186 and are connected toprimary shaft 176. Shafts 198 can be moved (extended and retractedrelative to handle 174) by any mechanism, such as by movement of primaryshaft 176 forward and back relative to handle 174. The angle or splay ofshafts 198 (i.e., the angle of extended shafts relative to alongitudinal axis extending through the handle) can be adjusted bymovement of angle adjustment 182.

Implant 200 as illustrated is a single-piece, e.g., integral meshimplant comprising a central tissue support portion, extension portionsextending in opposite directions from the tissue support portion, andself-fixating tips 202.

In use, with primary shaft 176 extended proximally away from handle 174,and shafts 198 retracted into handle 174, implant 200 can be placed atthe distal end of tool 188 with self-fixating tips 202 placed at each oftwo distal end adjusting surfaces 204. A user can grasp handle 174 andadjust the angle of the shafts 198 (relative to a longitudinal axis ofthe tool) by movement of angle adjustment 182. This may be referred toas a “non-extended” configuration (shafts 198 are non-extended). Thedistal end of tool 188, engaged with implant 200, can be insertedthrough the medial incision, whereupon surface 186 (also in contact withimplant 200) can contact tissue of a region of a urethra to push orotherwise contact or place pressure on the urethra, to assist inapproximating the urethra. Shafts 198 can then be extended(simultaneously) from handle 174 by movement of primary shaft 176 in adistal (toward the patient) direction while maintaining the position ofhandle 174 and surface 186. Self-fixating tips 202 become extended atdistal ends of shafts 198 to contact and become secured to supportivetissue (e:g., in a region of an obturator foramen) in the pelvic regionof the patient.

FIGS. 12A, 12B, and 12C, illustrate a method of using tool 188 to placesingle-piece implant 200, to treat urinary incontinence. Patient anatomyis as described previously. Referring to FIG. 12A, with tool 188 in anon-extended configuration and implant 200 located at the distal end oftool 188, the distal end, including implant 200, is inserted through amedial incision in a patient to locate implant 200 at a locationgenerally below a urethra. The angle of shafts 198 relative to alongitudinal axis of the tool can be adjusted (increased or decreased)by movement of angle adjustment 182. Surface 186 (also in contact withimplant 200) can contact tissue of a region of a urethra to push orotherwise contact or place pressure on the urethra, to assist inapproximating the urethra. Shafts 198 are extended (simultaneously) fromhandle 174 by movement of primary shaft 176 in a distal direction whilemaintaining the position of handle 174 and surface 186. Self-fixatingtips 202 become extended at distal ends of shafts 198, to contact andbecome secured to supportive tissue in the pelvic region of the patient.

FIG. 13 illustrates a system that includes implant 222 (e.g., fortreating male or female urinary incontinence) and one or more insertiontool 210. Implant 222 includes support portion 224, end or extensionportions 226, tissue fasteners (chevrons or barbs) 230 located onextension portions 226 near support portion 224, tail portions (e.g.,sutures) 216 extending from a distal end of each extension portion 226,connectors or dilators 238, and sheaths 228 which can be located alongthe lengths of extension portions 226 to cover tissue fasteners 230 (seeFIG. 14A)(as illustrated at FIG. 13 sheaths 228 are located over tailportions 216). Insertion tool 210 includes shaft 212, distal end 214,proximal end and handle 220, and an optional mechanical releasemechanism (e.g., detent) and trigger located at a proximal region ofshaft 12 (optional release mechanism and trigger are not shown). FIG. 13shows a single tool 210, having a helical shaft; optionally a system mayinclude two tools 210 each having a helical shaft, one helical shaftsuited to place an extension portion at a right side of a patient andone helical shaft suited to place an extension portion at a left side ofthe patient.

FIGS. 14A, 14B, and 14C, illustrate a method of using helically-curvedtool 210 to place implant 222 to treat urinary incontinence. Patientanatomy is as described previously. On a first side of a patient, distalend of helical insertion tool 210, engaged with connector 238, is usedto insert connector 238 through a medial incision, through an obturatorforamen and related tissue, around a pubic ramus bone (34) and thensubcutaneously back to the medial, midline perineal region. See FIG. 2A.Insertion tool 210 is then withdrawn and used to place the secondconnector 238 at a second side of the patient in a similar manner. SeeFIG. 14B. The implant can be adjusted and tensioned by adjusting theposition of the implant and the urethra, including adjusting theposition and tension of tail portions 216, which extend back to anexternal location through the medial incision. Once the urethra andimplant are positioned as desired, sheaths 228 can be removed to exposeextension portions 226, including tissue fasteners (anchors, barbs; orchevrons) 230 within tissue. See FIG. 14C.

FIG. 15 illustrates a system that includes two-piece implant 242 (e.g.,for treating male or female urinary incontinence), insertion tool (e.g.,10, 50, or 80), and adjusting (pusher) tool 254. Implant 242 includes afirst piece that includes support portion 244, one extension portion 246integrally connected to support portion 244, self-fixating tip 249,tissue anchors (chevrons or barbs) 245, and an aperture component 241(e.g., grommet, channel, optionally comprising a one-way ratchetconfiguration) of an adjusting engagement, the aperture component 241designed to engage a second component of the adjusting engagement.Extension portion piece 248 includes mesh portion 246, self-fixating tip249, tissue anchors (chevrons or barbs) 245, and nm1-mesh portion 250,which includes a second component of an adjusting mechanism in the formof ratcheting “cones,” teeth, or another form of ratchet surface, 252.Optionally (but not as illustrated) support portion 244 can be moveablealong the length of the implant between self-fixating tips 249.Optionally an adjusting tool 254 can be used to engage aperturecomponent 241 to assist in adjusting the adjusting engagement betweenaperture component 241 and ratchet surface 252. A proximal end ofnon-mesh portions 250 can be threaded through aperture 258 at distal end256 of tool 254, and distal surface 260, surrounding aperture 258, cancontact aperture component 241 to place pressure on aperture component241 while non-mesh portion 252 is drawn in a proximal direction (seearrow).

FIGS. 16A, 16B, and 16C, illustrate a method of using an insertion tool(e.g., 10) and adjusting tool 254 to place two-piece implant 242 totreat urinary incontinence. Patient anatomy is as described previously.A distal end of an insertion tool engaged with self-fixating tip 249 isused to insert self-fixating tip 249 through a medial incision and placeself-fixating tip 249 at supportive tissue in a region of an obturatorforamen on a first side of the patient. See FIG. 16A. The insertion toolis then used to engage the second self-fixating tip 249, and the secondself-fixating tip 249 can be placed at supportive tissue in a region ofan obturator foramen on a second side of the patient. A proximal end ofnon-mesh portion 250 can be placed through an aperture of aperturecomponent 241 and pulled to adjust a length of implant betweenself-fixating tips 249, to provide desired tension on the length ofimplant, and desired approximation, placement, and support of theurethra. See FIGS. 16B and 16C. Proximal end 250 may optionally bethreaded through aperture 258 of pusher tool 254, and pusher tool 254may optionally be used to push aperture component 241 in a distaldirection, toward self-fixating tip 249 located at the distal end ofmesh portion 246 of extension portion piece 248. A proximal portion ofnon-mesh portion 250 can then be removed by cutting. Before, after, orsimultaneously with reducing the length of implant by pulling non-meshportion 250 relative to aperture component 241, an optional moveablesupport portion (not shown) can be moved (slid) laterally in a directiontoward one or the other obturator foramen to place the moveable supportportion at a desired (central, medial) location below the urethra.

FIG. 17 A illustrates a system that includes implant 281 (e.g., fortreating male or female urinary incontinence) and insertion tool 290.Implant 281 includes support portion 284, end or extension portions 286,self-fixating tips 288, and tissue fasteners (chevrons, barbs) 289.Support portion 284 is moveable relative to self-fixating tips 288 bypassage through supports 285 located on support portion 284. Supports285 are adjusting engagements that allow support portion 284 to be movedand positioned at a desired location along a length of each extensionportion 286. The effect is to allow a user to reduce (or optionallyincrease) the effective size of each extension portion by sliding eachsupport 285 toward a respective self-fixating tip 288, on one or bothsides of the implant and patient, thereby reducing the overall length ofimplant 281 between self-fixating tips 288. As illustrated, supports 285include ratcheting springs 287, which are biased toward and contactperforations 283 of extension portions 286, resulting in a one-wayadjusting engagement between a support 285 and a perforated extensionportion 286.

FIG. 17B shows details of an exemplary tool 290, wherein handle 299 ismoved proximally (away from the patient) to draw shaft 293 in theproximal direction. Tool 290 can also optionally include a gauge tomeasure a state of adjustment of the implant during placement andadjustment, including tension in the implant during adjustment. Forexample, a gauge may measure the amount of tension applied to theextension portions of the implant by use of a pressure gauge thatmeasures pressure at surface 292. Alternately, a gauge may be used tomeasure pressure of tissue (e.g., corpus spongiosum) that becomesapplied to a distal end of the tool, e.g., at surface 294.

In use, after placement of self-fixating tips at a left and a right sideof a patient, tool 290 can be used to moved supports 285 distally alongsupport portions 286, toward self-fixating tips 288, to shorten thelength of implant between self-fixating tips 288. Movement of supports285 can be assisted by use of tool 290, which includes distal surface294 at an end of stationary shaft 296. Surface 294 is capable ofcontacting and approximating support portion 284, placed in contact withtissue of a urethra (e.g., corpus spongiosum, bulbospongiosus muscle).Puller 292 is located behind surface 294 and at a distal end of moveableshaft 293. To adjust lengths of extension portions 286, proximal loop276 is placed on a proximal side of puller 292, as surface 294 is placedagainst support portion 284, in contact with tissue of a urethra, andafter self-fixating tips are placed in supportive tissue. Moveable shaft293 is advanced in a proximal direction (see arrows), causing supportportion 284 to move distally along lengths of extension portions 286 andtoward self-fixating tips 288; i.e., proximal portions of extensionportions 286 are pulled in a proximal direction through supports 285.The result is to shorten the length of implant between self-fixatingtips 288, while approximating the urethra, and thereafter supporting theurethra with implant 281.

FIGS. 18A, 18B, and 18C, illustrate a method of using an insertion tool(e.g., 10, 50, or 80) and adjusting tool 290 to place implant 281 totreat urinary incontinence. Patient anatomy is as described previously.A distal end of an insertion tool is used to place self-fixating tips288 at a region of an obturator foramen on a first side and a secondside of the patient. See FIGS. 18A and 18B. Adjusting tool 290 is thenused to adjust the placement of the implant and the location of theurethra. For example, proximal loop 276 can be placed on a proximal sideof puller 292 as surface 294 is placed against support portion 284 andin contact with tissue of a urethra. Tool 290 can be used to approximatetissue of the urethra as desired. Moveable shaft 293 is advanced in aproximal direction causing support portion 284 to move distally alongthe lengths of extension portions 286 and toward self-fixating tips 288;i.e., proximal portions of extension portions 286 are pulled in aproximal direction through supports 285. The result is to shorten thelength of implant between self-fixating tips 288 while approximating theurethra, and thereafter supporting the urethra with implant 281. Tool290 can be removed and proximal loop 276 can be cut away.

FIG. 19 illustrates a system for treating urinary incontinence, thesystem comprising a multi-piece implant and an adjusting tool. Thesystem shares structural features with the systems illustrated elsewhereherein, including the systems of FIGS. 7 and 9, and can be used inmethods as described for those systems to place an implant into apatient using steps analogous to steps identified as useful with thosesystems. Adjusting tool 317 includes handle 360 and distal adjustingsurface 364, in contact with support portion piece 362. Shaft 318extends from a proximal shaft end at handle 360 to surface 364 definedadjacent to aperture 333. The curved distal surface 364 adjacent toaperture 333 is sized and shaped to contact and assist in approximatingtissue of a urethra (e.g., corpus spongiosum, bulbospongiosus muscle,etc.) during use of tool 317 to place an implant to support the urethra.

A multi-piece implant includes support portion piece 362 and twoextension portion pieces 370. Extension portion pieces 370 include amesh portion 344, a non-mesh portion 342, and self-fixating tip 346.Support portion piece 326 includes a surface to support a urethra havingtwo apertures 330; each aperture 330 can be a component of an adjustingengagement with non-mesh portion 342 or mesh portion 344. Non-meshportions 342 include a surface or structure that can frictionally engagean aperture 330 to provide an adjusting engagement between aperture 330and non-mesh portion 342, the adjusting engagement being, e.g., aone-way or a two-way adjusting engagement. As illustrated, non-meshportion 312 includes a polymeric rod that has surfaces that engage aone-way frictional structure (e.g., grommet) at each aperture 330.

In use, after placing each extension portion piece at a desired patientlocation, e.g., as described herein with self-fixating tips atsupportive tissue, support portion piece 326 can be placed at distalsurface 364 of tool 317 with apertures 330 seated to be accessed throughaperture 333. Proximal ends of extension portion pieces 370 can bepassed through aperture 330 and aperture 333. A user can grasp (by handor by use of a tool) a proximal end of each support portion piece 370 topull the proximal end in a proximal direction. Simultaneously, surface364 can be used to approximate tissue of a urethra by inserting thedistal end of tool 317 through a medial incision to contact tissue of aregion of a urethra, to push or otherwise contact or place pressure onthe urethra, to assist in approximating the urethra. The extensionportion pieces can be drawn through apertures 330 to adjust the lengthof the extension portions and the location of the tissue supportportion.

FIG. 20 illustrates a system for treating urinary incontinence, thesystem comprising a multi-piece implant and an adjusting tool. Thesystem shares structural features with the systems illustrated elsewhereherein, including the systems of FIGS. 7, 9, and 19, and can be used inmethods as described for those systems to place an implant into apatient using steps analogous to steps identified as useful for thosesystems. Compared to the system of FIG. 19, the system of FIG. 20includes similar features that include adjusting tool 317, handle 360,distal adjusting surface 364, support portion piece 362, extensionportion pieces 370, shaft 318, and surface 364 defined adjacent toaperture 333. As one difference, extension portion piece 370 of FIG. 20includes a proximal portion made of mesh (as a replacement for thenon-mesh portion). Also, tool 317 includes moveable holder (e.g., slideror “shuttle”) 372 moveable along a length of shaft 318 and guides 374located at a distal end of shaft 318, near surface 364. During use,proximal mesh portion 342 is guided through aperture 330 of supportportion piece 362, through guide 374 at a distal end of shaft 318, andthen can removably engage slider 372 by a removable mechanicalconnection such as a cleat, slot, slit, moveable jaws, a moveablefrictional device, or any mechanical securing device. Slider 372 can bemoved in a proximal direction to pull extension portion pieces in aproximal direction (toward handle 360 along shaft 318) relative tosupport portion 362 located against surface 365, while the distal end oftool 317 is used to approximate urethral tissue.

FIG. 21 illustrates a system for treating urinary incontinence, thesystem comprising a multi-piece implant and an adjusting tool. Thesystem shares structural features with the systems illustrated elsewhereherein, including the systems of FIGS. 7, 9, 19, and 20, and can be usedin methods as described as useful with those systems. Compared to thesystem of FIGS. 19 and 20, the system of FIG. 21 includes similarfeatures, identified numerically in a consistent manner. As onedifference, extension portion piece 370 of FIG. 21 includes a non-meshportion 380 that includes apertures. Non-mesh portion 380 can bethreaded through buckle 378 of support portion piece 326 to allowapertures of the non-mesh portion to selectively engage and disengagedbuckle 378. The adjusting engagement between support portion piece 362and extension portion pieces 370 is capable of being engaged,disengaged, adjusted, re-engaged, and disengaged, adjusted, andreengaged as necessary. The adjusting engagement is a two-way engagementthat can be selectively secured (e.g., “locked into place”), unsecured,and re-secured. Each support portion piece 370 can be used as described,by engaging supportive tissue, then threading support portion pieces 370through buckles 378. Each support portion piece 370 can then beindividually engaged (through an aperture 380) with buckle 378 and theimplant can be tested for positioning, tension, or support of theurethra. If desired, each support portion piece can be independentlydisengaged from buckle 378, adjusted, then re-engaged. Upon properplacement, support, tension, etc., a proximal portion of each supportportion piece can be trimmed.

FIG. 22 illustrates another system for treating urinary incontinence,the system comprising a multi-piece implant and an adjusting tool. Thesystem shares structural features with systems illustrated elsewhereherein, including the systems of FIGS. 7, 9, 19, 20, and 21, and can beused in methods described as useful for those systems. Compared to thesystem of FIG. 20, the system of FIG. 22 includes similar features thatinclude adjusting tool 317, handle 360, distal adjusting surface 364,support portion piece 362, extension portion pieces 370, shaft 318,slider or “shuttle” 372, and surface 364 defined adjacent to aperture333. As a difference, aperture piece 330 (e.g., of a metal such asstainless steel) is a two-way adjusting engagement that can be closed orlocked (e.g., mechanically crimped) to prevent subsequent movement ofnon-mesh portion 342 after adjustment of extension portion piece 370.

According to certain preferred methods of treating incontinence in amale, using implants as described, an implant can be placed below aurethra to contact tissue of a corpus spongiosum (by dissectingbulbospongiosus muscle), and the urethra can be approximated to improvecontinence without requiring the urethra to be compressed.

As described more specifically in US 2006-0287571-A1, according toexemplary embodiments of treating incontinence using any of the implantsor tools described herein, a tissue support portion of an implant can beplaced in a position to approximate and support a urethra, optionallywithout placing compressive forces on the urethra, to effect improvedcontinence (e.g., in a male patient). Preferably, for treatment of amale patient, a tissue support portion can be placed to contact tissueof a corpus spongiosum and then tensioned to cause approximation of thecorpus spongiosum and urethra in a direction toward a bladder,optionally with use of a tool as described herein for placing pressureon or moving the urethra. Accordingly, embodiments of the inventiongenerally, in a male patient, can relate to placement of a tissuesupport portion at a location that supports and is tensioned tore-position a urethra toward a bladder. The implant can be tensioned tocause the urethra—especially the posterior portion of urethra above aperineal membrane—to be moved from an abnormal (e.g., prolapsed ordescended) position to a position of normal healthy urethral tissuecapable of being fully coapted upon contraction of the rhabdosphincter.Alternate methods can cause compression of the urethra, but compressionis not required in methods that result in approximation of the urethrato improve continence.

According to these embodiments, a method of surgically installing aurethral implant can include providing a medial incision at the perineumof a male patient to expose bulbospongiosus muscle, optionally andpreferably dissecting through bulbospongiosus muscle to expose corpuspongiosum, and placing a tissue support portion of the implant tocontact the corpus spongiosum tissue. Optionally the tissue supportportion can be fixed to the corpus spongiosum, such as by use of amedical attachment in the form of a suture, staple, adhesive, or thelike. The implant can be adjusted, tensioned, etc., e.g. based on theuse of an adjusting engagement, an adjustment tool, or another means, toapproximate the urethra to improve continence, and tension canoptionally and preferably maintained chronically.

According to exemplary methods, the implant can be inserted through asingle medial (perineal or vaginal) incision (no external incision isrequired) and an extension portion of the implant can be attached tosupportive tissue within the pelvic region, such as tissue at a regionof an obturator foramen, or to tissue (e.g., fascia) that lies between aurethra and tissue of an obturator foramen, or other supportive tissue.According to such methods, a tissue fastener such as a self-fixating tipat a distal end or distal portion of an extension portion can be engagedat a distal end of an insertion tool (e.g. a curved elongate needle).The insertion tool can be used to place the tissue fastener andextension portion through a medial incision (of a male or femalepatient) and extend the tissue fastener and extension portion in adirection of an obturator foramen, e.g., to tissue of the obturatorforamen or to other supportive tissue. Features of the inventivemethods, implants, and tools that are described herein can beincorporated into such a technique, such as placement of the urethralsling below a urethra at a tissue of a bulbospongiosus muscle or acorpus spongiosum, approximation of the urethra to improve continence(without the need for compression of the urethra), etc., use of animplant that includes adjustable engagements (and steps of adjusting theimplant), use of an adjustment tool. This method avoids the need forlateral incisions at the inner thigh and adjacent to each opposingobturator foramen.

What is claimed is:
 1. A system for treating urinary incontinence, thesystem comprising a multi-piece implant comprising a support portionpiece and an extension portion piece, and an adjusting tool, wherein thesupport portion piece comprises a tissue support portion sized andshaped for placement to support a urethra, and the extension portionpiece comprises a proximal end, a distal end, and a tissue fastener, andis adjustably connected to the support portion piece at an adjustingengagement, and the adjusting tool comprises a surface capable ofengaging the support portion piece, and a moveable holder capable ofholding the proximal end of the extension portion piece and moving theproximal end relative to the adjusting engagement.